FDA Inspection 1044304 — A Plus Phlebotomy Services
The FDA completed an inspection of A Plus Phlebotomy Services on March 14, 2018 in Huntingdon Valley, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 14, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Huntingdon Valley, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 100 | 21 CFR 606.110(b) | Center approval for collection of rare antibodies |
| 114 | 21 CFR 606.121(c)(1) | Proper name of product |
| 123 | 21 CFR 606.121(c)(4)(i) | Expiration date |
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 15079 | 21 CFR 606.121(c)(11) | Required labeling information - manufacturing use |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 161 | 21 CFR 606.160(a)(2) | Determination of lot numbers and supplies |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9270 | 21 CFR 610.40(h)(2)(ii) | Labeling of reactive units, units from deferred donors |